About this trial
The study is to observe safety, survival effect and peripheral T-lymphocyte subsets of combination therapy with percutaneous microwave ablation (MWA) and adoptive immunotherapy in hepatocellular carcinoma(HCC).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
single HCC of 5 cm or smaller;
three or fewer multiple HCC with a maximum dimension of 3 cm or less;
absence of portal vein thrombosis or extrahepatic metastases;
Child-Pugh classification A or B;
Disqualifiers
pregnant or breast-feeding; psychiatric problems, addiction, or any other disorder that prevented informed consent;
active uncontrolled infection; concurrent systemic corticosteroid treatment;
systemic autoimmune disease;
clinically significant ischemic heart disease or cardiac failure;
Trial design
Parallel
Treatments tested in this trial
adoptive immunotherapy
Biological/VaccinePatients with HCC (tumor diameter ≤5 cm and fewer than three tumors) underwent radical MWA followed by cellular immunotherapy. In the CIK-based cohort, patients received 4-6 courses annually, starting at 2, 4, 6, 10, 14, and 18 weeks after MWA, followed by treatment every 12 weeks. Peripheral blood mononuclear cells were differentiated into phenotypically confirmed DCs and effector cells. DC-CIK and CTL were administered intraperitoneally, and CIK cells were infused intravenously. In the NK-cell cohort, patients received six NK-cell infusions at 2-week intervals after complete MWA and normalization of body temperature. NK cells were expanded ex vivo from autologous peripheral blood, allogeneic peripheral blood, or umbilical cord blood.
MWA
Procedure/SurgeryALL the HCC patients will be treated only by microwave ablation and then enter the follow-up
Treatment groups
Trial outcomes
Primary outcomes
Cumulative survival rates were calculated by the Kaplan-Meier method, and comparison between MWA and combination treatment will be done by the log-rank test.
Secondary outcomes
disease free survival rates were calculated by the Kaplan-Meier method, and comparison between MWA and combination treatment will be done by the log-rank test
Other outcomes
Local tumor progress rates were calculated by the Kaplan-Meier method, and comparison between MWA and combination treatment will be done by the log-rank test
Sponsors and contacts
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